Duns Number:025460908
Device Description: DBD-SUPPORT,ANKLE,ELASTIC,LG/XLG,MICROB,
Catalog Number
ORM26100LXLD
Brand Name
Curad
Version/Model Number
ORM26100LXLD
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
Yes
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
ITW
Product Code Name
JOINT, ANKLE, EXTERNAL BRACE
Public Device Record Key
0803bcf5-f2e0-41ba-9645-e0132df68476
Public Version Date
April 23, 2021
Public Version Number
1
DI Record Publish Date
April 15, 2021
Package DI Number
40884389816807
Quantity per Package
4
Contains DI Package
00884389816809
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
CASE
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 38540 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 85094 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 7 |